Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breastfeeding
  • Drug Effect
  • Obstetric Anesthesia Problems
  • Obstetric Pain
  • Opioid Use
  • Pain Acute
  • Pain, Chronic
  • Postpartum Depression
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective observational open-label trial (Part 1)Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 99 years
Gender
Only males

Description

Postpartum pain management strategies currently permit opioids for breakthrough pain, but strategies focused on minimizing or eliminating opioids are lacking. In the non-obstetric surgical population, modalities such as intravenous ketamine are well-recognized as effective adjuncts in opioid-reducti...

Postpartum pain management strategies currently permit opioids for breakthrough pain, but strategies focused on minimizing or eliminating opioids are lacking. In the non-obstetric surgical population, modalities such as intravenous ketamine are well-recognized as effective adjuncts in opioid-reduction strategies for postoperative pain. Although there have been some studies of ketamine exposure in postpartum women without deleterious outcomes noted, these studies in pregnant and lactating women are limited by a lack of information on maternal pharmacokinetics, breastmilk secretion, and clinical effectiveness when used with standard multimodal analgesic approaches. There is also a lack of information on intermediate and long-term outcomes in this setting. This two-part trial will address these knowledge gap by advancing understanding of the safety and efficacy of ketamine and its metabolites in peripartum populations.

Tracking Information

NCT #
NCT04037085
Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Grace Lim, MD, MS University of Pittsburgh